| Location: Onsite Status Type: Full Time QUALIFICATIONS Required: - Pursuing a bachelor’s degree in science, engineering, or a related field
Skills & Competencies: - Ability to participate as a team member
- Ability to work independently
- Good interpersonal and organizational skills
- Good written and verbal communication skills
- Strong understanding of Quality Systems Regulations
- Good time management skills
- Ability to follow defined procedures
- Ability to collaborate and maintain cooperative work relationships with others
- Ability to adapt to change and handle unexpected situations with close guidance
- Ability to stay focused on tasks, organize, compare, interpret basic data, and assess problems with guidance
Physical Requirements: - Must be able to remain in a stationary position for extended periods of time
- Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
- Ability to move about inside the office to access file cabinets, office machinery, etc.
- Position requires being physically present on the premises during regular company hours or as approved by management
RESPONSIBILITIES: - Assist with literature-based research and assist with responses to customer requests for information
- Assist in the preparation of master files, technical files, or other regulatory submissions
- Assist in the preparation of documentation needed to support investigational clinical studies
- Assist with country-specific labeling requirements
- Assist in tracking labeling, change controls, licenses, and registrations
- Identify areas for improvement, problem-solve, and suggest solutions
- Complete simple or basic tasks to include any of the following: writing and/or verifying specifications, maintaining product/process documentation
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